Cleared Abbreviated

K033019 - SUNPEX TECHNOLOGIES MODEL SE03

K033019 is an FDA 510(k) clearance for SUNPEX TECHNOLOGIES MODEL SE03, manufactured by Sunpex Technology Co., Ltd.. The device is a Class 2 Physical Medicine device with product code INI cleared through the Abbreviated 510(k) pathway after a 118-day FDA review.

K033019 · Sunpex Technology Co., Ltd. · Physical Medicine device
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Jan 2004
Decision
118d
Days
Class 2
Risk

K033019 is an FDA 510(k) clearance for the SUNPEX TECHNOLOGIES MODEL SE03. Classified as Vehicle, Motorized 3-wheeled (product code INI), Class II - Special Controls.

Submitted by Sunpex Technology Co., Ltd. (Baltimore, US). The FDA issued a Cleared decision on January 22, 2004 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.3800 - the FDA physical medicine device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sunpex Technology Co., Ltd. devices

FDA 510(k) Submission Details - K033019

510(k) Number K033019 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 2003
Decision Date January 22, 2004
Days to Decision 118 days
Submission Type Abbreviated
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 115d · This submission: 118d
Pathway characteristics
Standards-based clearance path.

INI Device Classification - Class 2, Special Controls

Product Code INI Vehicle, Motorized 3-wheeled
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.3800
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Physical Medicine devices follow this clearance model.

Regulatory Peers - INI Vehicle, Motorized 3-wheeled

All 191
Devices cleared under the same product code (INI) and FDA review panel - the closest regulatory comparables to K033019.
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